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Assessing Effects of a Denture Gel on Gum Abrasions

NCT04913636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-06-28

Study results available
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Summary

This is a parallel design study. Up to 40 subjects with a full mandibular and full maxillary dentures will be enrolled into the study. Subjects will use their current denture care +/- a treatment gel for 4 weeks. Subjects will have an Oral Soft Tissue exam, a Mucosa Condition Assessment, and a Pre-Gum Abrasion Evaluation followed by a peanut challenge and then have a Post-Gum Abrasion Evaluation at designated timepoints.

Conditions

  • Gum Injury

Interventions

DEVICE

Treatment Gel

In the evening subjects will perform their regular denture cleaning routine. They will be instructed to sleep without dentures. Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.

OTHER

Sham Control

Subjects will perform their regular denture cleaning routine.

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-06-29
Completion
2021-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04913636 on ClinicalTrials.gov